Major abdominal surgery for a number of diseases involving different parts of the gastro-intestinal and urinary tract can result in the patient being left with an abdominal stoma. The three most common types of abdominal stoma are the colostomy, the ileostomy, and the ileal conduit. In the case of an ileostomy, ileal conduit, and many colostomy operations, the patient is unable to control the passage of bodily waste material and must rely upon an appliance attached to their body to collect this material.
These appliances can be attached directly to the body by means of an adhesive faceplate or mounting gasket or can be attached to an ostomy washer or skin barrier which is fitted around the stoma.
A mounting gasket including a sealing ring formed from a karaya-glycerol gel is described by Marsan in U.S. Pat. No. 3,302,647. Ostomy washers formed of other materials have been taught in the art. For example, Etes in U.S. Pat. No. 3,640,741 discloses a washer formed of a cross-linked alginate or carboxymethylcellulose gum, Pratt in U.S. Pat. No. 3,612,053 describes an ostomy sealing washer formed from an oil-extended block copolymer having a water activatable adhesive on one surface, Marsan in U.S. Pat. Nos. 3,712,304 and 3,799,166 describes an ostomy seal made from starch and gelatinized starch cross-linked with glyoxal, Marsan in U.S. Pat. No. 3,878,847 describes a thin membrane that contacts the stoma, Marsan in U.S. Pat. No. 3,908,658 describes an ostomy seal formed from a gel of mineral oil, stryene-isobutylene copolymer and an ethylene-vinyl acetate copolymer, and Kross in U.S. Pat. Nos. 3,877,431 and 3,980,084 describes ostomy seals formed from polymeric materials.
Chen in U.S. Pat. No. 3,339,546 describes a bandage having an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethylcellulose, and polyisobutylene and a water insoluble polyethylene film which is currently employed as a skin barrier by ostomates. Other commercially available skin barriers contain a cloth mesh layer or polyethylene web sandwiches between two adhesive layers. The adhesive layers comprise a conventional pressure sensitive adhesive and a hydrocolloid.
In employing any of these systems it is difficult for the ostomate to achieve a tight fluid proof seal between the mounting gasket, washer, and/or skin barrier and the stoma. Leakage of the corrosive effluent from the stoma will eventually cause disintegration of the mounting gasket, washer, or skin barrier necessitating removal of the appliance. Also, this erosion can permit the corrosive effluent to contact the skin contiguous to the stoma causing serious irritation.
Ostomates having this problem employ various products to fill the area between the stoma and the gasket, washer, and/or skin barrier. Karaya powder is the most widely used product at this time. Various ointment or paste type products have been suggested and used by ostomates to protect the area of skin contiguous to the stoma including those taught by Steinhardt in U.S. Pat. No. 3,029,187, Cyr et al. in U.S. Pat. No. 3,029,188, Chen in U.S. Pat. No. 3,906,951, and Pichierri in U.S. Pat. No. 4,007,263.
Another problem facing many ostomates involves the actual attachment of the appliance. In order to secure the appliance and achieve a tight fit around the stoma, it is desirable that the body surface be relatively flat and smooth. An ostomate whose abdomen is flabby or who has scar tissue as a result of surgery may need to contruct a platform type of dressing by piecing together a skin barrier. The construction of such a dressing is both time consuming and expensive.